Eplex System
ePlex Respiratory Panel Kit, 12 test, IVD
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Genmark Diagnostics, Inc., United States |
|---|---|
| FDA product code | OZY |
| Device type | Chlamydophila Pneumoniae Dna Assay System |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3980 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K163636 |
| Record published | 2018-01-03 |
| Record revised | 2023-12-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ePlex Respiratory Panel (RP) | In distribution | |
| ePlex Respiratory Panel (RP) | In distribution | |
| ePlex Respiratory Panel (RP) | In distribution |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.